FirstWord Lists: FDA approvals since 2000 – Which companies have achieved the highest regulatory success and other key observations

Big Pharma has accounted for over two thirds of innovative drug approvals at the FDA since 2000; Novartis, Pfizer and Johnson & Johnson have been the most productive companies...

Since 2000, the FDA has approved 339 innovative new pharmaceutical products (those filed as new chemical entities [NCEs] or biologics applications [BLAs]), equal to an average of 26 per year.

As widely reported earlier this year, in 2012 the FDA approved the highest number of innovative new drugs – 39 – since 1996. The lowest number of approvals since 2000 occurred in 2007, when just 18 innovative products were authorised.

Novel biologics account for approximately 19 percent of total innovative approvals by the FDA since 2000 (63 products).

Big Pharma companies (for the purpose of this analysis any company with 2012 pharma revenues in excess of $15 billion; see below for list) have received 133 innovative drug approvals since 2000, equal to 39 percent of the total.

Big Pharma's 'influence' over the approval rate for innovative products has fluctuated over the previous 12 years.

During the period 2000-2004, Big Pharma accounted for nearly 38 percent of innovative approvals, with this ratio slipping to 33 percent over the period 2004-2008 as the industry's largest players suffered a notable slow down in new launches. Over the period 2008-2012, however, Big Pharma accounted for just over 38 percent of all innovative approvals by the FDA.

This pattern is also reflected by the number of Big Pharma NCE/BLA approvals for each of the overlapping time periods; 52, 39 and 55, respectively.

European and US-based Big Pharma players have fared similarly in terms of regulatory success since 2000, with US companies accounting for 48 percent of Big Pharma approvals, European-based companies for 50 percent and Japanese companies (Takeda) for 2 percent.

Novartis has been the most productive company in terms of NCE/BLA approvals since 2000, gaining 21 nods from the FDA over this period (equal to an impressive 16 percent of total Big Pharma approvals over this period), followed by Pfizer (16), Johnson & Johnson (15), GlaxoSmithKline (14) and Sanofi (10).

A strong track record in terms of FDA approvals was evident when Johnson & Johnson and Novartis reported Q2 results last week, with both companies recording sizeable revenues from products launched in the recent past. See ViewPoints: Zytiga spearheads robust Q2 performance for Johnson & Johnson, but management suggests caution on patent exclusivity for key cancer franchise and ViewPoints: Five key takeaways from Novartis' Q2 results

In contrast, AbbVie (Abbott Laboratories prior to 2013) has only secured approval of two innovative products with the FDA since 2000, the most recent of these being Humira in 2002 (a product that the company is heavily reliant on in terms of revenue - see FirstWord Lists – Big Pharma's Blockbuster dependency rates).

Takeda (3 approvals), AstraZeneca (5) and Amgen (5) are notable in terms of low approval numbers; one caveat here being that neither Takeda or Amgen are 'established' Big Pharma players in the nature of AstraZeneca. The latter's weak performance in terms of new drug approvals since 2000 is an obvious precursor to the challenges that the company now faces.

The number of approvals gained by the FDA since 2000 only provides limited insight into the productivity of the companies listed. There is some correlation, however, reflected by both Johnson & Johnson and Novartis reporting robust Q2 results last week, notably driven by strong revenues generated from products launched in the recent past.

FirstWord has previously analysed the proportion of 2012 revenues derived from products launched over the previous five-year period for selected Big Pharma companies – that analysis can be read here.

To read more List articles, click here.